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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

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Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

NICE Declines to Recommend Pfizer's Lung Cancer Drug

Posted 28 March 2013 | By Louise ZornozaRegLink

In draft guidance released on 27 March 2013, the UK's National Institute for Health and Clinical Excellence (NICE) declined to recommend National Health Service coverage of Pfizer's Xalkori (crizotinib).&nbsp; &nbsp;

Crizotinib is a tyrosine kinase inhibitor (TKI), and works by blocking enzymes that otherwise could stimulate cancerous growth. Crizotinib blocks a specific enzyme called anaplastic lymphoma kinase (ALK) which is present in some non-small-cell lung cancers. Although the drug was found to provide an additional 5.1 months in progression free survival over the comparator lung cancer drug (docetaxel), NICE determined that the drug is not cost effective, as it does not meet its criteria to qualify as an "end of life" drug.&nbsp;

NICE will normally recommend reimbursement for treatments that cost around &pound;20,000 to &pound;30,000 per quality life year (QALY) or less. If a drug meets the criteria to be considered an end of life treatment, there is no set threshold cost per QALY.&nbsp; However, the highest cost per QALY of an end of life recommended drug has been around &pound;50,000. The Committee concluded that the most plausible cost per QALY would lie somewhere between &pound;63,800 and &pound;181,100 for crizotinib compared with docetaxel, and between &pound;51,700 and &pound;80,500 for crizotinib compared with best supportive care.

Commenting on the decision, NICE Chief Executive Sir Andrew Dillon said: "We have already recommended a number of treatments for the various stages of non-small-cell lung cancer. However, although the independent committee that considered the evidence found crizotinib to be clinically effective treatment for ALK-positive non-small-cell lung cancer, even if the supplementary advice to the Committee for life-extending treatments had applied, crizotinib could not be considered a cost-effective use of NHS."